BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOLLOS

    MDR report key: 16329722 · Received February 8, 2023

    Report

    Report Number
    3008406502-2023-00001
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    January 18, 2023
    Report Date
    January 30, 2023
    Manufacturer
    1073849 ONTARIO LTD., DBA TOLLOS, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FACILITY REPORTED THAT A PATIENT LIFT FELL FROM THE OVERHEAD TRACK THROUGH A GATE SYSTEM THAT IS DESIGNED TO PREVENT THIS. EMPLOYEE OF THE FACILITY WAS ALLEGEDLY INJURED, HOWEVER, THE MANUFACTURER HAS NOT BEEN GIVEN ANY DETAILS ABOUT THIS INJURY. MANUFACTURER IS SHIPPING DEVICE BACK TO FACTORY FOR EVALUATION AND TESTING.

    Description of Event or Problem · 0

    THE EVENT INVOLVES A GATE SYSTEM CALLED "AUTO-GATE" BECAUSE IT OPENS WHEN TWO RAILS ARE ALIGNED, ALLOWING THE LIFT TO PASS THROUGH FROM ONE RAIL ONTO THE OTHER, AND CLOSES WHEN THE RAILS ARE NOT ALIGNED IN ORDER TO STOP THE LIFT FROM FALLING OUT OF THE END OF THE GATE. STAFF MEMBER RAN EMPTY LIFT (NO PATIENT INVOLVED) INTO THE AUTO-GATE PIN WHEN THE RAILS WERE NOT ALIGNED. LIFT WENT THROUGH THE GATE AND FELL TO THE GROUND. LIFT ALLEGEDLY HIT STAFF MEMBER IN THE FOOT. THE REPORTER/MANUFACTURER DOES NOT HAVE MUCH INFORMATION ABOUT THIS EVENT, BUT BELIEVES THAT THE STAFF MEMBER SUSTAINED AN INJURY. THE SEVERITY OF THIS INJURY IS NOT KNOWN TO TOLLOS (THE MANUFACTURER AND REPORTER). PLEASE NOTE THAT THE INDIVIDUAL THAT WAS ALLEGEDLY INJURED WAS NOT A PATIENT, BUT RATHER A STAFF MEMBER. THE AGE GIVEN UNDER THE PATIENT INFORMATION SECTION (SECTION A) IS NOT THE TRUE AGE OF THE INDIVIDUAL INVOLVED. THE MANUFACTURER HAS NOT BEEN PROVIDED WITH THE AGE OF THE STAFF MEMBER; HOWEVER, THIS FORM (3500A) WILL NOT ALLOW SUBMISSION WITHOUT THE AGE INFORMATION ENTERED. THE MANUFACTURER HAD TO PUT IN A NUMBER IN ORDER TO SUBMIT THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358255 TOLLOS PATIENT LIFT (CEILING LIFT) FSA 1073849 ONTARIO LTD., DBA TOLLOS, INC. CIRRUS

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Prefer Not To Disclose